Senior Director, Biostatistics & Clinical Analytics

PTC Therapeutics, Inc.; Warren Township (NJ); Hybrid; USD 239,000 - 281,000; Full time

Job summary

PTC Therapeutics, Inc. seeks a Senior Director of Biostatistics to lead statistical strategy across clinical programs and ensure quality deliverables for regulatory submissions. The role partners with clinical, regulatory, and commercial teams in a fast-paced environment.

You will guide study design, analysis plans, and communications with regulators, while managing vendors and cross-functional teams in a hybrid work setting. Travel is expected.

Qualifications

• Advanced degree in Statistics and 12+ years in pharma/CRO
• Experience supporting clinical studies and interacting with regulators
• Knowledge of regulatory submissions (NDA/BLA/MAA)
• Ability to influence without authority
• Strong written and verbal communication and time management

Responsibilities

• Ensure timely statistical deliverables for trial results, analyses and publications
• Develop solutions for statistical and data analysis issues across teams
• Participate in protocol development including study design and power calculations
• Author and manage SAPs and integrated summaries for submissions
• Support NDAs/BLAs submissions and external partnerships data reviews
• Travel 5-15% as required

Skills

Statistics

Clinical trials

Regulatory affairs

Data analysis

Vendor management

Communication skills

Project management

Independent work

Education

Advanced degree in Statistics

Job description

PTC Therapeutics, Inc. seeks a Senior Director of Biostatistics to lead statistical strategy across clinical programs and ensure quality deliverables for regulatory submissions. The role partners with clinical, regulatory, and commercial teams in a fast-paced environment.

You will guide study design, analysis plans, and communications with regulators, while managing vendors and cross-functional teams in a hybrid work setting. Travel is expected.